A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule.

A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule. - RABBIT-14

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008702

Enrollment

Registered

2012-08-23

Start date

2012-09-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-grade B-cell non-Hodgkin&#39

Interventions

Standard regimen group bendamustine Day1, 2 120mg/m2/ day 1 cycle consists of 21 days Benda-14 regimen group bendamustine Day1, 15 120mg/m2/ day 1 cycle consists of 28 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Pathological diagnosis of low-grade B-cell non-Hodgkin's lymphoma or a mantle cell lymphoma on the basis of biopsy. 2.Patients who did not enter in partial remission (PR) by chemotherapy(except single adrenocortical hormones), or relapsed after attaining complete remission (CR) or PR.Regardless of the number and the type of ex-chemotherapy. 3.Being able to have 4 weeks washout period of anticancer drug.(two weeks washout for Rituxan and Zevalin) 4.CD20 positive. 5.lWith measurable lesion (>1.5cm on the CT scan) 6.Age 20 to 80 at the time of registration. 7.ECOG Performance Status 0-2. 8.Patients who meet all the following standards within 14 days before registration. a.Neutrophil count : More than 1,000/mm3 b.Hemoglobin :>= 8.0 g/dL c.blood platelet count :>=100,000/mm3 d.AST, ALT in the blood: less than 2.5 times normal level e.T-BIL in the blood <=2.0 mg/dl f.Serum creatinine : <=2.0 mg/dl g.Electrocardiogram :normal or not required to be treated. h.SpO2:>=95% 9.Expected at least 3 months survival. 10.Agree to participate in this study with written consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant women or nursing mothers. In postmenopausal women within a year. Women and men who cannot prevent pregnancy or do not have intension to prevent during the treatment period 2.With active double cancer (synchronous double cancer or metachronous double cancer which have 5-years of disease-free, except for basal cell carcinoma, squamous cell carcinoma, carcinoma in situ which goes into remission by topical treatment, or lesion part equivalent to intramucosal carcinoma.) 3.With mental disease or neurologic manifestation considered to be difficult to participate in this study. 4.HBs antigen positive. 5.HIV antibody-positive. 6.With a lot of tumor cells in peripheral blood (more than 25,000/&micro;L). 7.having received hematopoietic stem cell transplantation. 8.With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration). 9.With CNS infiltration. 10.Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment. 11.With severe drug hypersensitivity. 12.Judged as inappropriate for this study by the investigator.

Design outcomes

Primary

Measure	Time frame
Completion rate of 6 cycles	—

Secondary

Measure	Time frame
Overall response rate;ORR Complete response rate;CR Event-free survival;EFS Progression-free survival;PFS Safety(frequency and severity of adverse events and adverse drug reactions) Immune-function monitoring(CD4 lymphocyte count, CD4 / 8 ratios )	—

Countries

Japan

Contacts

Public ContactHisashi Wakita

Japanese Red Cross Society Narita Hospital Department of Hematology and Oncology

0476-22-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin&#39;s lymphoma or mantle cell lymphoma comparing administration schedule.